WARNING
RETROVIR (ZIDOVUDINE) HAS BEEN ASSOCIATED WITH HEMATOLOGIC TOXICITY INCLUDING NEUTROPENIA AND SEVERE ANEMIA PARTICULARLY IN PATIENTS WITH ADVANCED HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE (SEE WARNINGS). PROLONGED USE OF RETROVIR HAS BEEN ASSOCIATED WITH SYMPTOMATIC MYOPATHY.
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION, INCLUDING RETROVIR AND OTHER ANTIRETROVIRALS (SEE WARNINGS).
|
| |
RETROVIR SUMMARY
RETROVIR®
(zidovudine)
Tablets
RETROVIR®
(zidovudine)
Capsules
RETROVIR®
(zidovudine)
Syrup
RETROVIR is the brand name for zidovudine (formerly called azidothymidine [AZT]), a pyrimidine nucleoside analogue active against human immunodeficiency virus (HIV).
RETROVIR in combination with other antiretroviral agents is indicated for the treatment of HIV infection.
Maternal-Fetal HIV Transmission: RETROVIR is also indicated for the prevention of maternal-fetal HIV transmission as part of a regimen that includes oral RETROVIR beginning between 14 and 34 weeks of gestation, intravenous RETROVIR during labor, and administration of RETROVIR Syrup to the neonate after birth. The efficacy of this regimen for preventing HIV transmission in women who have received RETROVIR for a prolonged period before pregnancy has not been evaluated. The safety of RETROVIR for the mother or fetus during the first trimester of pregnancy has not been assessed (see Description of Clinical Studies).
|
RETROVIR NEWS HIGHLIGHTS Media Articles Related to Retrovir (Zidovudine)
Also In Global Health News: Malawi ARV Program; Health Care In Gaza; Pneumonia Vaccine In Kenya; South African Pregnant Women And HIV; More
Source: HIV / AIDS News From Medical News Today [2009.06.30]
Malawian Government Supplies 250,000 HIV-Positive Citizens With Free Antiretrovirals The government of Malawi supplies 250,000 of its HIV positive citizens with antiretrovirals (ARVs) free of charge, Malawian President Bingu wa Mutharika said during an AIDS candlelight memorial outside of the capital city, Blantyre, on Sunday, the
Gladstone Scientists Identify Key Factor That Controls HIV Latency
Source: Immune System / Vaccines News From Medical News Today [2009.06.28]
Scientists at the Gladstone Institutes of Virology and Immunology (GIVI) have found another clue that may lead to eradication of HIV from infected patients who have been on antiretroviral therapy. A real cure for HIV has been elusive because the virus can "hide" in a latent form in resting CD4-T cells. By understanding this "latency" effect, researchers can identify ways to reactivate the virus and enable complete clearance by current or future therapies.
Quarter of a million Malawians on free HIV drugs: president (AFP)
Source: Y! Health HIV & AIDS News [2009.06.28]
AFP - Malawi is supplying 250,000 HIV positive citizens with free anti-retrovirals (ARVs) and plans to start producing anti-AIDS drugs locally, President Bingu wa Mutharika said Sunday.
IRIN Examines PEPFAR Funding Of IDU Programs
Source: Alcohol / Addiction / Illegal Drugs News From Medical News Today [2009.06.25]
IRIN examines a recent comment piece in the journal Lancet that argues PEPFAR can do more to prevent the spread of HIV among injecting drug users (IDUs) in Africa (IRIN, 6/24). Although PEPFAR has helped to provide "antiretroviral therapy to 2.
Arizona ADAP Cuts Number Of Medications Covered Under Program
Source: Liver Disease / Hepatitis News From Medical News Today [2009.06.12]
The Arizona AIDS Drug Assistance Program (ADAP) has reduced the number of medications it will cover - antiretrovirals and drugs that treat opportunistic infections will not be affected, the Arizona Daily Star reports. The program relies heavily on federal funding. Judy Norton, chief of the state's Office of HIV, STD and Hepatitis C Services, said the state received $2.
Published Studies Related to Retrovir (Zidovudine)
Early antiretroviral therapy and mortality among HIV-infected infants. [2008.11.20]
BACKGROUND: In countries with a high seroprevalence of human immunodeficiency virus type 1 (HIV-1), HIV infection contributes significantly to infant mortality. We investigated antiretroviral-treatment strategies in the Children with HIV Early Antiretroviral Therapy (CHER) trial... CONCLUSIONS: Early HIV diagnosis and early antiretroviral therapy reduced early infant mortality by 76% and HIV progression by 75%. (ClinicalTrials.gov number, NCT00102960.) 2008 Massachusetts Medical Society
Switch from zidovudine- to non-zidovudine-containing regimens is associated with modest haematological improvement and no obvious clinical benefit: a substudy of the ANRS 099 ALIZE trial. [2008.11]
BACKGROUND: Zidovudine, the first antiretroviral agent, has short-term haematological toxicity. However, it is unclear whether patients tolerating long-term zidovudine-containing regimens will benefit from a switch to non-zidovudine-containing regimens... CONCLUSIONS: A switch from a long-standing zidovudine- to a non-zidovudine-containing regimen modestly improves haematological parameters and is not associated with obvious clinical benefit.
Phase II study of vicriviroc versus efavirenz (both with zidovudine/lamivudine) in treatment-naive subjects with HIV-1 infection. [2008.10.15]
BACKGROUND: Vicriviroc (VCV) is a CCR5 antagonist with nanomolar activity against human immunodeficiency virus (HIV) replication in vitro and in vivo. We report the results of a phase II dose-finding study of VCV plus dual nucleoside reverse-transcriptase inhibitors (NRTIs) in the treatment-naive HIV-1-infected subjects... CONCLUSIONS: VCV administered with dual NRTIs in treatment-naive subjects with HIV-1 infection had increased rates of virologic failure, compared with efavirenz plus dual NRTIs. No treatment-limiting toxicity was observed. Study of higher doses of VCV as part of combination therapy is warranted.
Didanosine, lamivudine, and efavirenz versus zidovudine, lamivudine, and efavirenz for the initial treatment of HIV type 1 infection: final analysis (48 weeks) of a prospective, randomized, noninferiority clinical trial, GESIDA 3903. [2008.10.15]
BACKGROUND: The combination of didanosine, lamivudine, and efavirenz (ddI/3TC/EFV) for the initial treatment of human immunodeficiency virus type 1 (HIV-1) infection has been insufficiently analyzed in clinical trials... CONCLUSIONS: At week 48, ddI/3TC/EFV administered once per day with food did not have results inferior to those of COM/EFV treatment. A statistically significantly higher proportion of patients in the COM/EFV arm than in the ddI/3TC/EFV arm discontinued therapy because of adverse events, mainly because of hematological toxicity. CLINICAL TRIALS REGISTRATION: NCT00256828.
A randomized trial of combination hepatitis B therapy in HIV/HBV coinfected antiretroviral naive individuals in Thailand. [2008.10]
CONCLUSION: LAM monotherapy resulted in a greater proportion of subjects with HBV DNA >3 log(10) c/mL at week 48 and in early resistance development. This study confirms current treatment guidelines that recommend a TDF-based regimen as the treatment of choice for HIV/HBV coinfection, but does not demonstrate any advantage of HBV combination therapy in this short-term setting.
Clinical Trials Related to Retrovir (Zidovudine)
Trial of Maraviroc (UK-427,857) in Combination With Zidovudine/Lamivudine Versus Efavirenz in Combination With Zidovudine/Lamivudine [Active, not recruiting]
Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown
to be active in vitro against a wide range of clinical isolates (including those resistant to
existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy
for 10 days reduced HIV-1 viral load by up to 1. 6 log, consistent with currently available
agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at
300 mg twice daily. No significant effects were seen on the QTc interval. The goal of this
study is to compare the safety and efficacy of maraviroc (UK-427,857) versus efavirenz, when
each are combined with two other antiretroviral agents, in patients who are previously naive
to antiretroviral therapy. This study will involve approximately 200 centers from around the
world to achieve a total randomized subject population of 1071 subjects. Patients will be
randomly assigned to one of three groups: maraviroc (UK-427,857) 300 mg once daily added to
zidovudine/lamivudine (300 mg/150 mg twice daily), Maraviroc (UK-427,857) 300 mg twice daily
added to zidovudine/lamivudine (300 mg/150 mg twice daily) or efavirenz (600 mg once daily)
added to zidovudine/lamivudine (300 mg/150 mg twice daily). The study will enroll over
approximately an 18 month period (5 months Phase 2b run-in, 13 months Phase 3) with 96 weeks
of treatment. This may be extended for an additional 3 years depending on the results at 96
weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24,
32, 40, 48, 60, 72, 84 and 96. Blood samples will also be taken at study entry, weeks 2, 4,
8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96. Additionally, blood samples will be drawn
twice, at least 30 minutes apart, at weeks 2 and 48 for maraviroc (UK-427,857)
pharmacokinetic analysis. As part of this clinical study a blood sample will be taken for
non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram
at study entry, weeks 24, 48 and 96. A computerized tomography (CT) scan will also be
performed, at selected centers, at study entry and week 96. Patients will be asked to
complete a symptom distress questionnaire at study entry, weeks 12, 24, 48 and 96.
A Randomized Trial to Evaluate the Safety and Efficacy of Combination Therapy With Retrovir ( AZT ) and HIVID ( ddC ) Versus Retrovir, HIVID, and Wellferon ( Interferon Alfa-n1 ) for the Treatment of HIV Infection [Completed]
Primary: To determine whether the combination of zidovudine/zalcitabine/interferon alfa-n1
(Retrovir/HIVID/Wellferon) can produce complete responses (i. e., CD4 counts return to >= 800
cells/mm3 for more than 24 weeks) in patients with virus sensitive to all three agents. To
determine the antiviral effect of the combination therapies as evidenced by measures of
quantitative viral load performed at select study centers only.
Secondary: To determine the effectiveness of Retrovir/HIVID and Retrovir/HIVID/Wellferon in
maintaining or increasing CD4 counts and preventing disease progression as evidenced by the
development of an AIDS-defining indicator disease. To determine the effect of these regimens
on secondary measures of clinical status (e. g., performance score, weight change, and
secondary infections) and on measures of virologic activity such as serum p24 antigen. To
assess the safety and tolerance of these regimens.
A Multi-Center, Placebo-Controlled, Double-Blind, Randomized Trial Comparing the Virologic and Immunologic Activities of 400 Mg Nevirapine in Combination With Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 4-12 Months of Prior Zidovudine Therapy and 200-500 CD4+ Cell [Completed]
PRIMARY: To compare the virologic activity (quantitative RNA PCR, quantitative PBMC) of the
combination of nevirapine and zidovudine (AZT) versus AZT alone after 3 and 6 months of
treatment. To compare the effects of these two regimens on CD4 T-cell count and percentage.
SECONDARY: To compare and evaluate other markers of immunologic and virologic activity in
patients receiving nevirapine/AZT versus AZT alone. To compare the effects of the two
regimens on clinical signs and symptoms. To evaluate the safety and tolerance of the two
regimens.
A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases [Completed]
The purpose of this pilot study is to evaluate the efficacy of Retrovir (AZT) in the
treatment of AIDS-related dementia and various neuromuscular complications. HIV is both a
lymphotropic and neurotropic virus which can affect both the central and peripheral nervous
systems (CNS, PNS). There is evidence that the CNS and PNS may harbor the virus in a latent
state, with the potential for continuous reinfection of other body systems. Therefore,
effective therapeutic efforts against HIV infection should provide effective antiviral
activity within the nervous system.
A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease [Active, not recruiting]
To facilitate the use of zidovudine (AZT) in children who are 3 months to 12 years of age who
are HIV-infected and either symptomatic or have a CD4 cell count < 400 cells/mm3 and to
monitor adverse effects of AZT.
Previous studies with pediatric patients have shown improvements in clinical, immunologic,
and virologic parameters with administration of AZT.
|
|
|
|
Page last updated: 2009-06-30
|
